Transapical implantation of a self-expanding aortic valve bioprosthesis--animal feasibility study.

Abstract

BACKGROUND: Severe peripheral arterial disease may pose a limitation to the applicability of trans-arterial aortic valve implantation in patients who are otherwise candidates. For this reason, transapical aortic valve implantation has been proposed as a possible alternative. OBJECTIVE: To evaluate the acute safety and performance of a specially designed delivery system, the CoreValve Tranzap delivery catheter, for the transapical implantation of a self-expandable aortic valve prosthesis in a porcine animal model. METHODS: Thirteen pigs were implanted with a self-expandable aortic valve bioprosthesis using a 21F catheter delivery system through a transapical approach. The delivery system was evaluated for: (1) the ability to access the implantation site; (2) the ability to precisely position the delivery catheter; (3) control of the delivery of the prosthesis; (4) safe retrieval of the delivery catheter; and (5) the ability to close the apical access site of the heart. RESULTS: Successful implantation was achieved in 100% of the cases. The following points were achieved in all animals: (1) passage of the delivery catheter through an incision in the left ventricular apex; (2) positioning of the delivery catheter on the implantation site; (3) controlled deployment of the aortic valve prosthesis; (4) the safe retrieval of the delivery catheter system; and (5) the adequate closure of the apex of the heart. CONCLUSION: This study demonstrates the acute safety and feasibility of the CoreValve Tranzap delivery system for the transapical implantation of the CoreValve self-expanding aortic valve bioprosthesis in a porcine animal model.